Summary Company Announcement Date: August 08, 2025 FDA Publish Date: August 09, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Contamination with Burkholderia cepacia Company Name: DermaRite Industries, LL Brand Name: Brand Name(s) DermaKleen, Dermasarra, Kleenfoam, and Perigiene Product Description: Product Description OTC antiseptic lotion soaps, external analgesics, antimicrobial foam soaps, and antiseptic…
Early Alert: WATCHMAN Access System Issue from Boston Scientific
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Boston Scientific has issued…
FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live): FDA Safety Communication
AUDIENCE: Patient, Health Care Professional, Pharmacy, Cardiology, Neurology, Internal Medicine, Family Practice, Travel Clinics ISSUE: On May 9, 2025, FDA issued a safety communication informing the public that the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) jointly recommended a pause in the use of Ixchiq (Chikungunya Vaccine, Live) in individuals…
Early Alert: Electrophysiology Catheter Issue from Medline ReNewal
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Medline ReNewal has issued…
Friendly’s Issues Allergy Alert on Undeclared Soy/Wheat in Friendly’s Cookies & Cream Ice Cream
Summary Company Announcement Date: August 05, 2025 FDA Publish Date: August 06, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared wheat and soy allergens Company Name: DFA Dairy Brands, LLC Brand Name: Brand Name(s) Friendly’s Product Description: Product Description Cookies and Cream Ice Cream Company Announcement Friendly’s Ice Cream…
Early Alert: Defibrillation Lead Issue from Boston Scientific
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Boston Scientific has issued…
Hans Kissle LLC Issues Allergy Alert on Undeclared Wheat (Allergen) in Hans Kissle Red Potato Bliss Salad
Summary Company Announcement Date: August 05, 2025 FDA Publish Date: August 05, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared wheat Company Name: Hans Kissle Brand Name: Brand Name(s) Hans Kissle Product Description: Product Description Red Bliss Potato Salad Company Announcement Haverhill, MA — Hans Kissle is voluntarily recalling…
FDA is Requiring Opioid Pain Medicine Manufacturers to Update Prescribing Information Regarding Long-Term Use: Drug Safety Communication
AUDIENCE: Patient, Health Care Professional, Pain Management ISSUE: In May 2025, the FDA convened a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee to discuss two recently completed observational studies examining the risks of misuse, abuse, addiction, and fatal and non-fatal overdose in…
Continuous Ventilator Correction: Philips Respironics Updates Use Instructions for BiPAP A30, A40, and V30 Devices Due to Interruptions and/or Loss of Therapy
This recall involves correcting devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. Affected Product Product Name UDI / Model Number Lot/Serial Numbers…
High Noon Announces Recall of its Vodka Seltzer Beach Pack (12 Pack) Due to Inclusion of CELSIUS® ASTRO VIBE ™ Energy Drink Cans that were Inadvertently Filled with Vodka Seltzer
Summary Company Announcement Date: July 29, 2025 FDA Publish Date: July 30, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Cans contain alcohol Company Name: High Noon Brand Name: Brand Name(s) High Noon, Celsius Product Description: Product Description Energy Drink Company Announcement MODESTO, CA, July 29, 2025 – High Noon is…